Lifting the covers on how drug companies buy influence and manipulate the system at the expense of patient safety and health, three doctors from the National Institutes of Health (NIH) are accusing drug maker Eli Lilly of acting improperly to influence treatment guidelines for sepsis. The accusation is contained in a letter published in this weeks New England Journal of Medicine

Dr. Peter Eichacker of the National Institutes of Health. He and two other NIH staff, Dr. Charles Natanson and Dr. Robert Danner, accuse Lilly of mounting a well financed campaign to influence guidelines on sepsis that favored its drug Xigris. that was “an extension of a pharmaceutical marketing campaign.”

Dr. Peter Eichacker sat on a review panel for Xigris and voted against approval of the drug which can cause severe bleeding. Dr Eichacker was not alone in his concerns about the drug, as half of the members of the safety advisory panel that reviewed the drug voted against approval. The FDA still approved the drug in 2001 after just one safety trail. found Xigris may modestly reduce deaths from sepsis..

Sepsis is a deadly infection that strikes about 700,000 people a year and has a very high mortality rate. The seriousness of sepsis was the justification for rushing the drug approval. The one trail found Xigris modestly reduced deaths from sepsis..

However, in a later study it was found that the drug could cause serious bleeding in some patients. Safety concerns, questions about the drugs effectiveness, and the high number of votes against approval reduced expected sales of the drug.

In the drug company campaign a $1.8 million grant was setup for a group of doctors and medical ethicists to push the use of the drug through questionable practices.

According to the letter, the marketing campaign “appears to have usurped guideline development for commercial purposes, possibly compromising highly regarded, third-party arbiters of medical quality in the process”.

Source
England journal of Medicine